RenovoRx, Inc. reports news on targeted oncology drug delivery, the commercialization of RenovoCath®, and clinical development of its TAMP™ therapy platform. The company is a life-sciences issuer developing localized cancer therapies and commercializing RenovoCath, a patented FDA-cleared drug-delivery device used for temporary vessel occlusion and chemotherapeutic drug infusion.
Recurring updates cover RenovoCath adoption at U.S. cancer centers, intellectual-property protection for the device, financing activity, financial results, and presentations of clinical or pharmacologic data. News also tracks IAG, the investigational intra-arterial gemcitabine product candidate delivered via RenovoCath, including disclosures tied to the TIGeR-PaC trial in locally advanced pancreatic cancer and orphan drug designations for pancreatic and bile duct cancer.
RenovoRx (RNXT) announced the acceptance of three abstracts for presentation at major industry conferences: ASCO GI 2025, SIO 2025, and SSO 2025. The abstracts focus on the company's Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, presenting additional human pharmacokinetic data and pre-clinical results.
The presentations will highlight RenovoRx's novel approach using their FDA-cleared RenovoCath® delivery platform, which is designed to deliver targeted oncology therapies directly to tumor sites while potentially reducing toxicity compared to systemic treatments. The company's ongoing Phase III TIGeR-PaC clinical trial is evaluating their first product candidate, combining RenovoCath with gemcitabine chemotherapy. RenovoRx expects to complete both patient enrollment and the second interim analysis for TIGeR-PaC by the end of H1 2025.
RenovoRx continues to grow its intellectual property (IP) portfolio, boasting 18 issued patents and 13 pending patents, as it advances commercialization and clinical trials in 2025.
The company recently published a new international patent application for its Trans-Arterial Micro-Perfusion (TAMP) therapy platform, which targets and delivers treatments directly to specific tissues using micro-vessels.
RenovoRx holds 8 issued and 6 pending U.S. patents and 10 issued and 7 pending patents outside the U.S., including its 2024 international application.
The TAMP technique aims to deliver therapies precisely to tumor sites, potentially reducing toxicities compared to systemic intravenous treatments.
RenovoRx's Phase III TIGeR-PaC clinical trial, evaluating its first product candidate using the FDA-cleared RenovoCath device, is expected to complete patient enrollment and the second interim analysis by mid-2025. The company also received its first purchase orders for the RenovoCath device.
RenovoRx (RNXT) announces the initiation of patient enrollment at SCRI Oncology Partners in Nashville for its pivotal Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer (LAPC). The study evaluates the TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform, comparing intra-arterial gemcitabine delivery via RenovoCath against standard intravenous chemotherapy.
Dr. Meredith Pelster, Associate Director for GI Research at Sarah Cannon Research Institute (SCRI), has been appointed as Principal Investigator. The company expects to complete enrollment in the first half of 2025. SCRI Oncology Partners, part of a network reaching one in five cancer patients across 250+ locations in 24 U.S. states, joins other clinical sites participating in the study.
RenovoRx (Nasdaq: RNXT) has announced an upcoming investor fireside chat scheduled for Tuesday, December 17, 2024, at 4:30 p.m. ET. CEO Shaun Bagai will discuss the company's 2024 achievements and 2025 outlook, focusing on two key areas:
1. The commercialization strategy for the RenovoCath delivery system, including insights from newly appointed Commercial Advisor Richard Stark
2. Updates on the pivotal Phase III TIGeR-PaC clinical trial, which evaluates their proprietary TAMP™ therapy platform for locally advanced pancreatic cancer treatment. The trial combines their RenovoCath delivery system with gemcitabine chemotherapy.
Important 2025 milestones include the anticipated second interim data readout and completion of patient enrollment in the TIGeR-PaC study. The event will include a Q&A session, and a recording will be available on RenovoRx's Investor Relations website.
RenovoRx (NASDAQ: RNXT) has received its first purchase orders for its FDA-cleared RenovoCath® delivery system, with over ten medical institutions initiating the purchase process nationwide. The company estimates an initial target market size of several hundred million dollars in annual sales for RenovoCath, which is powered by their patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform.
The device has been successfully used in over 500 clinical trial procedures. RenovoRx is pursuing a direct-to-market commercialization strategy and has expanded its relationship with manufacturing partner Medical Murray to increase production. The company expects to complete patient enrollment and the next interim analysis of its Phase III TIGeR-PaC clinical trial by the end of H1 2025.
RenovoRx (RNXT) announces that Northwell Health Cancer Institute (NHCI) has joined its pivotal Phase III TIGeR-PaC clinical trial for locally advanced pancreatic cancer (LAPC). The trial evaluates RenovoRx's TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform, comparing intra-arterial gemcitabine delivery via the FDA-cleared RenovoCath system to standard intravenous chemotherapy. NHCI joins other U.S. clinical sites in the study, which aims to complete enrollment in the first half of 2025.
RenovoRx reported Q3 2024 financial results with $9.6 million in cash as of September 30, sufficient to fund operations through next interim analysis of its Phase III TIGeR-PaC clinical trial and RenovoCath commercialization efforts. The company reported a net loss of $2.5 million, with R&D expenses at $1.7 million and G&A expenses at $1.2 million. RenovoCath, their FDA-cleared delivery system, is advancing towards commercialization with increased production and potential revenue generation in 2025. The Phase III trial for locally advanced pancreatic cancer is progressing towards completion of patient enrollment, expected in first half of 2025.
RenovoRx (Nasdaq: RNXT) announces increased production of its FDA-cleared RenovoCath® delivery system due to high demand from oncologists and interventional radiologists. The company has expanded its relationship with manufacturing partner Medical Murray, issuing a warrant for up to 709,500 shares of RenovoRx common stock as performance incentives. RenovoRx remains committed to its Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer (LAPC), using the TAMP™ therapy platform.
The company is exploring commercial opportunities for RenovoCath as a standalone device, with plans to launch during 2025. RenovoRx has promoted Robert Strasser to Vice President of R&D and Operations to support these efforts. The company maintains sufficient cash to fund both the next interim read-out on TIGeR-PaC and RenovoCath go-to-market activities.
RenovoRx (RNXT) announced that Dr. Ripal Gandhi will present at the Symposium on Clinical Interventional Oncology, highlighting the company's TAMP (Trans-Arterial Micro-Perfusion) therapy platform for treating locally advanced pancreatic cancer (LAPC). The presentation will focus on:
1. Clinical challenges of standard LAPC treatments
2. TAMP as a potential targeted oncology option
3. Status of the ongoing Phase III TIGeR-PaC study
4. Recent publication in The Oncologist® on early-stage clinical data
The presentation will take place on September 21, 2024, at 9:30am ET in Miami Beach, Florida. Dr. Gandhi, a principal investigator for RenovoRx's TIGeR-PaC trial since 2018, will discuss how TAMP may offer LAPC patients an alternative to systemic chemotherapy, which often has effectiveness and severe side effects.
RenovoRx (Nasdaq: RNXT), a clinical-stage biopharmaceutical company, announced that CEO Shaun Bagai will present at H.C. Wainwright's 26th Annual Global Investment Conference on September 9, 2024 at 7:00 a.m. ET in New York City. Bagai will discuss:
- Progress on the pivotal Phase III TIGeR-PaC clinical trial for Locally Advanced Pancreatic Cancer (LAPC) using their proprietary TAMP™ therapy platform
- New commercial business development opportunities for their FDA-cleared RenovoCath® delivery system
The company recently appointed Ryan Witt as Senior Vice President of Corporate Strategy and Partnerships in June 2024. A webcast of the presentation will be available, and one-on-one investor meetings can be scheduled through H.C. Wainwright or KCSA Strategic Communications.